Evaluation of an Integrated Care Project

Completed

• Conditions: Allergic Rhinitis; Migraine; Headache; Depression; Asthma; Atopic Eczema

• Registration Number: NCT01854580
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The purpose of the study is to investigate the effectiveness and cost-effectiveness of the integrated care program of a statutory health insurance offering additional homeopathic treatment to their members

Detailed Description

The German statutory health insurance 'Techniker Krankenkasse' offers an integrated additional homeopathic treatment. To date, this offer has not been evaluated. Therefore we aim to investigate the effectiveness as well as the cost-effectiveness of this program in adolescents (12-17 years) and adults with various chronic diseases.

In an observational study we plan to compare patients participating in the integrated care project with matched insured persons from the Techniker Krankenkasse that do not participate in this program.

Matching will be based on gender, age and diagnosis. Regarding the diagnosis, we plan to include adolescents with: asthma, allergic rhinitis and atopic eczema; and adults with asthma, allergic rhinitis and atopic migraine, headache and depression.

To measure effectiveness, patients have to complete diagnosis-specific questionnaires at baseline and 3, 6 and 12 months. The primary outcome for each diagnosis is measured with diagnosis-specific questionnaire at 6 months. Secondary outcomes include quality of life (SF-12) at 3, 6 and 12 months as well as the diagnosis-specific questionnaires at 3 and 12 months.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-15
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3960

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis-specific patient reported outcomes	6 months	Questionnaires: asthma: AQLQ, (PAQLQ for adolescents) allergic rhinitis: RQLQ (AdolRQLQ for adolescents) atopic eczema: DLQI (CDLQI for adolescents) migraine and headache: days with headache (last 4 weeks) tension headache: days of headache within the last 4 weeks

Secondary Outcome Measures

Name	Time	Method
Costs	3, 6, and 12 months period
Health related quality of life (SF-12)	3, 6 and 12 months
Diagnoses-specific patient reported outcomes	3 and 12 months	same parameters as for primary outcome, but different time point

Trial Locations

Locations (1)

Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany